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FDA sees no need for advisory panel meeting over Pfizer’s Ibrance

09-01-2015

US pharma giant Pfizer says it has been advised by the Food and Drug Administration that at this time…

IbranceOncologypalbociclibPfizerPharmaceuticalRegulationUSA

GW and Otsuka report Sativex failed to meet primary endpoint in cancer pain

GW and Otsuka report Sativex failed to meet primary endpoint in cancer pain

09-01-2015

UK-based GW Pharmaceuticals and Japanese drugmaker Otsuka have reported that Sativex (nabiximols) did…

AnalgesiaGW PharmaceuticalsOncologyOtsuka PharmaceuticalPharmaceuticalResearchSativexUKUSA

Aveo Oncology appoints Michael Bailey as president

Aveo Oncology appoints Michael Bailey as president

07-01-2015

Aveo Oncology has appointed Michael Bailey as president, chief executive and director.

AVEO OncologyBoardroomOncologyPharmaceuticalUSA

FDA grants Soligenix Fast Track status for SGX301

FDA grants Soligenix Fast Track status for SGX301

07-01-2015

Late-stage biopharma company Soligenix has said that its SGX301 (synthetic hypericin) development program…

OncologyPharmaceuticalRegulationSGX301SoligenixUSA

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

23-12-2014

The US Food and Drug Administration yesterday granted accelerated approval to US pharma major Bristol-Myers…

Bristol-Myers SquibbKeytrudaMerck & CoOncologyOpdivoPharmaceuticalRegulationUSA

Eli Lilly receives marketing authorization from the European Commission for Cyramza

Eli Lilly receives marketing authorization from the European Commission for Cyramza

22-12-2014

Eli Lilly has received marketing authorization from the European Commission for its drug Cyramza.

CyramzaEli LillyOncologyPharmaceuticalUSA

AstraZeneca’s Lynparza gains FDA approval

AstraZeneca’s Lynparza gains FDA approval

20-12-2014

The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s…

AstraZenecaLynparzaOncologyPharmaceuticalRegulationUSA

Cardinal Health and Bayer sign 15-year contract manufacturing agreement for Xofigo

Cardinal Health and Bayer sign 15-year contract manufacturing agreement for Xofigo

19-12-2014

Cardinal Health and German drug major Bayer have signed a 15-year agreement for the contract manufacturing…

BayerCardinal HealthLicensingOncologyPharmaceuticalProductionUSAXofigo

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

17-12-2014

The US Food and Drug Administration has approved Somatuline Depot (lanreotide) injection 120mg, manufactured…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

FDA approves third indication for Lilly’s Cyramza

FDA approves third indication for Lilly’s Cyramza

13-12-2014

The US Food and Drug Administration on Friday expanded the approved use of pharma major Eli Lilly’s…

CyramzaEli LillyOncologyPharmaceuticalRegulationUSA

Merck presents early data on Keytruda in advanced triple-negative breast cancer

Merck presents early data on Keytruda in advanced triple-negative breast cancer

11-12-2014

Pharma giant Merck & Co says Keytruda (pembrolizumab) has achieved an overall response rate of 18.5%…

KeytrudaMerck & CoOncologyPharmaceuticalResearchUSA

Merck’s new Gardasil 9 gains backing from US FDA

Merck’s new Gardasil 9 gains backing from US FDA

11-12-2014

The US Food and Drug Administration yesterday approved pharma giant Merck & Co’s Gardasil 9-valent…

Gardasil 9Merck & CoOncologyPharmaceuticalRegulationUSAVaccines

ASH 2014: Gilead announces good response rates for Zydelig in non-Hodgkin lymphoma

ASH 2014: Gilead announces good response rates for Zydelig in non-Hodgkin lymphoma

09-12-2014

US biotech major Gilead Sciences has announced long-term follow-up results from the registration studies…

Gilead SciencesOncologyPharmaceuticalResearchUSAZydelig

ASH 2014: Merck reports overall response rate of 66% for its Keytruda in Hodgkin's lymphoma

ASH 2014: Merck reports overall response rate of 66% for its Keytruda in Hodgkin's lymphoma

08-12-2014

Keytruda (pembrolizumab), manufactured by pharma giant Merck & Co, has achieved an overall response rate…

KeytrudaMerck & CoOncologyPharmaceuticalResearchUSA

ASH 2014: AbbVie's venetoclax shows promise in Phase II trial

ASH 2014: AbbVie's venetoclax shows promise in Phase II trial

08-12-2014

US drugmaker AbbVie presented data at the American Society of Hematology’s annual meeting, demonstrating…

AbbVieOncologyPharmaceuticalResearchUSA

Exelixis’ cabozantinib fails to meet primary endpoint in Phase III prostate cancer trial

Exelixis’ cabozantinib fails to meet primary endpoint in Phase III prostate cancer trial

02-12-2014

US biotech firm Exelixis has announced top-line results from the final analysis of COMET-2, a randomized,…

cabozantinibExelixisOncologyPharmaceuticalResearchUSA

Sources say GSK to cut hundreds of jobs in the US following oncology business sale to Novartis

Sources say GSK to cut hundreds of jobs in the US following oncology business sale to Novartis

01-12-2014

Sources close to the company have said UK pharma major GlaxoSmithKline is to announce hundreds of job…

AdvairGSKOncologyPharmaceuticalProductionSocial IssuesUSA

Janssen submits NDA for Yondelis in soft tissue sarcoma

Janssen submits NDA for Yondelis in soft tissue sarcoma

25-11-2014

US health care giant Johnson & Johnson’s subsidiary Janssen Research & Development has submitted a…

Janssen Research and DevelopmentOncologyPharmaceuticalRegulationUSAYondelis

US FDA pushes back decision date for Novartis’ panobinostat

US FDA pushes back decision date for Novartis’ panobinostat

25-11-2014

The US Food and Drug Administration has extended its priority review period by up to three months for…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

Clear survival benefit for B-MS’ Opdivo in advanced melanoma patients

Clear survival benefit for B-MS’ Opdivo in advanced melanoma patients

17-11-2014

US drug major Bristol-Myers Squibb has announced results from a study comparing Opdivo (nivolumab) to…

Bristol-Myers SquibbOncologyOpdivoPharmaceuticalResearchUSA

Global melanoma market set to reach $3.6 billion by 2020

12-11-2014

The global melanoma therapeutics market was valued at $1.3 billion in 2013 and will expand at a compound…

Bristol-Myers SquibbEuropeJapanKeytrudaMarkets & MarketingMerck & CoOncologyOpdivoPharmaceuticalUSAYervoy

Dendreon seeks a buyer as it files for bankruptcy

Dendreon seeks a buyer as it files for bankruptcy

10-11-2014

US biotech firm Dendreon has filed voluntary petitions under Chapter 11 of the Bankruptcy Code in the…

DendreonFinancialOncologyPharmaceuticalProvengeUSA

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

10-11-2014

Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have…

OncologyPerjetapertuzumabPharmaceuticalRegulationRocheUSA

FDA advisory panel votes against approval of Novartis MM drug

07-11-2014

At a meeting yesterday, the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC)…

LBH589NovartisOncologypanobinostatPharmaceuticalRegulationUSA

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